CELL AND GENE THERAPY

Bio-Techne Signs License Agreement with Luminary Therapeutics for the Use of TcBuster™ for the Manufacturing of Gene-modified Cell Therapies

Bio-Techne | February 25, 2021

Bio-Techne Corporation today declared the signing of a license agreement with Luminary Therapeutics for the utilization of TcBuster™ for the manufacturing of gene-modified cell therapies. TcBuster is Bio-Techne's proprietary non-viral transposon-based gene delivery system used to advance cell therapy manufacturing.

Under the provisions of this agreement, Bio-Techne grants Luminary Therapeutics a non-exclusive license for TcBuster. Luminary Therapeutics will utilize TcBuster in their LMY-920 program, a BAFF-CAR-T product. Luminary Therapeutics intends to file an IND with the FDA later this calendar year.

"This agreement with Luminary Therapeutics brings Bio-Techne's cutting-edge TcBuster system one step closer to delivering gene-modified cell therapies," said Dave Eansor, President of Bio-Techne's Protein Sciences Segment. "With this license agreement, Bio-Techne will increase its presence as a key player in the cell and gene therapy market."

About Luminary Therapeutics
Luminary Therapeutics is a pre-clinical cell therapy company developing next generation non-viral autologous cell treatments for cancers and autoimmune diseases. Luminary's primary focus is to develop CAR T and other next generation cell therapies that address the antigen escape issue present with existing therapies. Luminary utilizes Bio-Techne's TcBuster™ transposon technology to reduce safety concerns, costs, and time delays associated with viral based cell therapies. Located in Minneapolis, Luminary's team is comprised of cellular therapy veterans, industry leaders, and world-renowned cancer geneticist leaders from top biotech and consulting organizations. Luminary seeks novel next generation licensing opportunities with strong intellectual property (IP) for the treatment of solid tumors and in underserved disorders.

Spotlight

CSIR-NCL has successfully grown saffron crocus in a greenhouse and got flowering almost like that in Kashmir. The method is suitable for places where the cool deficit is not too much as compared to Kashmir and can be managed by some degree of environmental control using natural processes for cooling and some amount of freezing. It is expected to benefit progressive farmers and Agri-Biotech industries.

Spotlight

CSIR-NCL has successfully grown saffron crocus in a greenhouse and got flowering almost like that in Kashmir. The method is suitable for places where the cool deficit is not too much as compared to Kashmir and can be managed by some degree of environmental control using natural processes for cooling and some amount of freezing. It is expected to benefit progressive farmers and Agri-Biotech industries.

Related News

Stemcyte Submitted its Application for A Biologics License (BLA) For Its Product "HPC-Cord Blood" To The US FDA

Stemcyte | March 23, 2022

On January 7th, 2022, the FDA received the BLA (Biologics License Application) for the "HPC-Cord Blood" product. On March 8th, 2022, StemCyte was formally informed that the submission was acceptable to join the biologics license quality review process. The "HPC-Cord Blood" is an umbilical cord blood hematopoietic stem cell product intended for unrelated donor hematopoietic progenitor cell transplantation procedures in patients with hematopoietic system disorders an appropriate preparative regimen for hematopoietic and immunologic reconstitution. There have been over 40,000 successful umbilical cord blood transplants globally to treat disorders of the hematological and immunological systems and genetic metabolic diseases since the first successful use of umbilical cord blood to treat Fanconi Anemia patients in 1988. StemCyte has donated more than 2,200 cord blood units for transplantation to 1 in every 20 patients with umbilical cord blood transplants globally during the last 20 years. In addition, at least 350 transplant centers around the world, including well-known medical centers such as UCLA Medical Center, Duke University Hospital, Taiwan Chang Gung Memorial Hospital, and National Taiwan University Hospital, consistently meet the quality standards of international accrediting bodies and are recognized and trusted as safe and effective by StemCyte's products.

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INDUSTRIAL IMPACT

Adaptive Biotechnologies Announces New Data Demonstrating ImmunoSEQ® Technology Can Identify T-Cell Receptors Associated with Crohn’s Disease

Adaptive Biotechnologies | February 19, 2022

Adaptive Biotechnologies Corporation a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, presented data on T-cell receptor (TCR) sequences associated with Crohn’s disease (CD) during an oral presentation today at the 17th Congress of European Crohn’s and Colitis Organisation (ECCO) being held virtually February 16-19. The study identified and characterized TCR sequences associated with CD utilizing Adaptive’s immunoSEQ® technology, providing fundamental insights into the body’s response to CD at the cellular level. The immunoSEQ assay uses sequencing technology to decipher the complexity of the adaptive immune system. This multi-national study, which was also recently published in The Journal of Crohns and Colitis, utilized immunoSEQ technology to analyze TCRs from blood samples of 1,738 CD cases and 4,970 healthy donors. Intestinal tissue samples from a subset of 380 cases were also analyzed. Through this analysis, 1,121 CD-associated TCRs were identified in patients’ blood and verified in tissue. The identification of disease-specific TCRs is an important first step in identifying a signal and developing an algorithm to inform development of a diagnostic test for CD. “The study identified Crohn’s-specific TCRs in both the blood and tissue of patients with Crohn’s disease, including a large subset that are ’public,’ or shared among patients. These findings suggest that blood-based testing for this often-debilitating disease could be used to diagnose and more effectively manage the disease through the identification of these disease specific T-cell receptors.” Matthieu Allez, MD, PhD, Professor and Head, Department of Gastroenterology, Hospital Saint-Louis, Paris T cells can have a significant impact on inflammation in CD, but until now, disease-associated TCRs have been largely unknown and underleveraged in diagnostics for the disease.1 These findings show that immunoSEQ can successfully identify TCRs for CD in a blood sample, which is reflective of the TCRs in intestinal tissue. The average length of time from onset of symptoms to diagnosis for a CD patient can be 1-2 years in the US but may be much longer in other countries, so the potential to open a new path to identify the disease earlier is significant.2,3 Furthermore, the amount of Crohn’s-related TCRs can provide insights into disease characteristics such as the phenotype and location of the disease, with possible clinical implications. In addition to TCR findings, the analysis also studied the possible association between human leukocyte antigens (HLAs) alleles and CD-associated TCRs, which live on most cells in the body, by leveraging the novel immunoSEQ HLA Classifier. HLA alleles are genetic factors that have been found to contribute to a small portion of risk for CD. In this study, nearly 400 CD-associated TCRs were found to be associated with specific HLA alleles. These TCR associations highlight the importance of studying TCRs in the context of HLA type and potentially point to new risk factors and insights for CD such as the involvement of specific antigens that the immune system may be reacting to in people living with CD. “We’re excited to see these results and their potential to advance the scientific community’s understanding of the immune response to Crohn’s disease. The use of immunoSEQ and characterization of TCRs in the blood have the potential to uncover new knowledge on the development and progression of the disease, with the potential to eventually improve diagnostic options and disease management for people living with Crohn’s,” said Harlan Robins, PhD, Chief Scientific Officer and Co-Founder of Adaptive Biotechnologies. “We look forward to continuing our research and advancing the development of our T-Detect test to include an application in the diagnosis of Crohn’s disease.” CD is a subtype of inflammatory bowel disease, a group of diseases impacting about 6.8 million adults globally.4 Early treatment with effective medications can prevent disease progression towards complications, surgery and disability. However, CD is difficult to diagnose and treat, with more than half of patients initially misdiagnosed. No single blood test currently exists for diagnosis of CD. Instead, patients often undergo a series of tests – often invasive – in order to reach a conclusive diagnosis. Based on the results of this study, Adaptive is further investigating specific TCR signatures that are associated with CD related behavior and disease activity to further the development of T-Detect in this indication. Additional research will also focus on signal optimization and clinical validation to explore commercial utility. About the immunoSEQ® Assay Adaptive’s immunoSEQ Assay helps researchers make discoveries in areas such as oncology, autoimmune disorders, infectious diseases and basic immunology. The immunoSEQ Assay can identify millions of T- and/or B-cell receptors from a single sample in exquisite detail. The immunoSEQ Assay is used to ask and answer translational research questions and discover new prognostic and diagnostic signals in clinical trials. The immunoSEQ Assay provides quantitative, reproducible sequencing results along with access to powerful, easy-to-use analysis tools. The immunoSEQ Assay is for research use only and is not for use in diagnostic procedures. About T Detect™ T-Detect™ is a highly sensitive and specific diagnostic test under development for multiple diseases, translating the natural diagnostic capability of T cells into clinical practice. In 2018, Adaptive and Microsoft partnered to build a map of the immune system called the TCR-Antigen Map. This approach uses immunosequencing, proprietary computational modeling, and machine learning to map T-cell receptor sequences to disease-associated antigens for infectious diseases, autoimmune disorders and cancer. From a simple blood draw, T-Detect will leverage the map to provide an immunostatus for an individual, enabling early disease diagnosis, disease monitoring, and critical insights into immunity. T-Detect COVID is the first clinical test launched from this collaboration and the first commercially available T-cell test designed to detect recent or prior SARS-CoV-2 infections. T-Detect COVID is not FDA-cleared or approved, it has received an EUA from the FDA and is available for prescription use only. About Adaptive Biotechnologies Adaptive Biotechnologies is a commercial-stage biotechnology company focused on harnessing the inherent biology of the adaptive immune system to transform the diagnosis and treatment of disease. We believe the adaptive immune system is nature’s most finely tuned diagnostic and therapeutic for most diseases, but the inability to decode it has prevented the medical community from fully leveraging its capabilities. Our proprietary immune medicine platform reveals and translates the massive genetics of the adaptive immune system with scale, precision and speed to develop products in our Immune Medicine and Minimal Residual Disease (MRD) businesses. We have three commercial products and a robust clinical pipeline to diagnose, monitor and enable the treatment of diseases such as cancer, autoimmune conditions and infectious diseases.

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CDI Labs Announces the Addition of Its SARS-CoV-2 (COVID19) Assay Platform

PR Newswire | August 21, 2020

CDI Laboratories, Inc. announced the addition of its SARS-CoV-2 (COVID19) assay platform. The assays use CDI's VirScan service which can detect antibodies to 1345 individual viral strains representing species from 76 viral genera. This is coupled with CDI's 2 in 1 SARS-CoV-2 antigen microarray which contains overlapping SARS-CoV-2 peptides as well as full-length proteins. This will allow researchers, therapeutic developers, and vaccine developers, to analyze human serum for all known viruses as well as epitope level data on COVID19 antibodies. In addition, CDI has added the COVID19 S and N proteins to CDI's HuProtTM proteome microarray. CDI's VirScan is the first commercial use of the incredibly powerful PhIP-seq technology (Xu, George J et al. SARS-COV-2 "Viral immunology. Comprehensive serological profiling of human populations using a synthetic human virome." Science (New York, N.Y.) vol. 348,6239 (2015): aaa0698. doi:10.1126/science.aaa0698). These p

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